MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

EXACTECH, INC.

The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Modification To Exactech Acumatch Integrated Hip System, M-series High Off-set Neck Segment, M-series Low Off-set Neck S.

Pre-market Notification Details

• Device ID: K010120
• 510k Number: K010120
• Device Name: MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Contact: Gary J Miller
• Correspondent: Gary J Miller; EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-01-16
• Decision Date: 2001-02-09
• Summary: summary

NIH GUDID Devices

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